Achiel Van Peer
Janssen Research Foundation, Dept. of Clinical Pharmacokinetics, Turnhoutseweg 30, B-2340 Beerse (Belgium)
An overview will be given of the actual status and ongoing talks to come to an harmonised guideline on studies in special patient populations, A guideline acceptable for the EC, Japan and US has been drafted now after discussions between representatives from industry and authorities. The current proposal focuses on geriatrics and drug interactions, and discusses the use of formal studies and the pharmacokinetic screening approach.
Reference: PAGE 2 (1993) Abstr 916 [www.page-meeting.org/?abstract=916]
Poster: oral presentation